Will ABILIFY make me gain weight?

On average, patients taking ABILIFY gained 2.2 pounds over a year. Significant weight gain (an increase of 7% or more in body weight) varied based on body mass index (BMI), a measure of weight in relation to height, and ranged from 8% to 30% of patients.

Will ABILIFY make me feel sleepy or tired?

In clinical trials involving adults with Schizophrenia, 10% of patients taking ABILIFY tablets felt sleepy or tired, compared with 8% of patients taking a placebo (sugar pill). You should not drive or operate hazardous machinery until you know how ABILIFY affects you.

Does ABILIFY affect sexual function?

In clinical studies of adults with Schizophrenia, incidence of patient-reported sexual-related adverse reactions was similar in the ABILIFY and placebo groups.

Will ABILIFY affect my prolactin levels?

On average, in clinical studies, ABILIFY did not elevate prolactin levels.

Will ABILIFY affect my blood sugar or cholesterol?

In clinical trials, blood sugar and cholesterol levels were similar among patients taking ABILIFY and those taking a placebo.

• Diabetes: Risk factors for diabetes include obesity, family history of diabetes, or unexpected increases in thirst, urination, or hunger
• Increases in blood sugar levels (hyperglycemia): In some cases, serious risks related to increases in blood sugar associated with coma or death have been reported in patients taking ABILIFY and medicines like it
• Ask your healthcare professional about the need to monitor your blood sugar level before and during treatment.

Please see IMPORTANT SAFETY INFORMATION concerning increases in blood sugar levels.

Will ABILIFY cause movement problems (EPS*)?

In clinical studies, about 1 in 5 people on ABILIFY reported one or more of the following: restlessness, muscle stiffness, tremors, shakes or ticks, or other involuntary movements.
*Extrapyramidal symptoms.

What common side effects should I know about?

The most common side effects (reported by at least 5% of ABILIFY patients and twice as often as patients taking a sugar pill) reported by patients with Schizophrenia.

Adults: inner sense of restlessness or need to move (akathisia).

Adolescents (13 to 17 years of age): extrapyramidal disorder (such as shakes, muscle stiffness, or other involuntary movements), sleepy or tired, and tremor (shakiness).

Overall, the percentage of people discontinuing ABILIFY because of side effects was similar for patients treated with ABILIFY (7%) and patients treated with placebo (sugar pill) (9%) in the adult Schizophrenia trials. The percentage of adolescents discontinuing ABILIFY because of side effects was 5% compared to 2% treated with placebo.

Please see IMPORTANT SAFETY INFORMATION concerning other common side effects.
 

Tracking and monitoring side effects

Everyone responds differently to medication. Side effects you may be experiencing can be related to numerous factors, such as medications you may be taking in addition to ABILIFY or changes in daily routine.

If you experience side effects, keep track of what you are noticing and talk to your doctor. This will help your doctor understand how your medication is working, whether it is affected by other medications you may be taking, and how to manage your side effects.

Do not stop taking your medication without first talking to your healthcare professional even if you feel your symptoms are in control. Stopping your medication could increase your risk of relapse. Always talk to your doctor before making changes in your treatment plan.

ABILIFY and other medications

You may be taking other medications in addition to ABILIFY. Keep in mind that people respond to medications differently, and medications may interact with each other. Make sure that you talk to your doctor about all the medications you are currently taking. Together, you can discuss how ABILIFY may work with these other medications.

Are there additional important safety considerations I should know about?

Elderly patients, diagnosed with psychosis as a result of dementia (for example, an inability to perform daily activities as a result of increased memory loss), and who are treated with antipsychotic medicines including ABILIFY, are at an increased risk of death when compared to patients who are treated with a placebo (sugar pill). ABILIFY is not approved for these patients.

Some medicines can increase suicidal thoughts and behaviors in children, teens, and young adults. Serious mental illnesses are themselves associated with an increase in the risk of suicide. When taking ABILIFY call your doctor right away if you have new or worsening mood symptoms, unusual changes in behavior, or thoughts of suicide. Patients and their caregivers should be especially observant for such symptoms within the first few months of treatment or after a change in dose.

Contraindication: Patients should not use ABILIFY if they are allergic to aripiprazole or any of the ingredients in ABILIFY. Allergic reactions have ranged from rash, hives and itching to anaphylaxis, which may include difficulty breathing, tightness in the chest, swelling of the mouth, face, lips, or tongue.

Serious side effects may include:

• An increased risk of stroke and ministroke have been reported in clinical studies of elderly people with dementia-related psychosis
• Very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood pressure. These may be signs of a condition called neuroleptic malignant syndrome (NMS), a rare but serious side effect which could be fatal
• Abnormal or uncontrollable movements of face, tongue, or other parts of body. These may be signs of a serious condition called tardive dyskinesia (TD), which could become permanent
• If you have diabetes, or risk factors for diabetes (for example, obesity, family history of diabetes), or unexpected increases in thirst, urination, or hunger, your blood sugar should be monitored. Increases in blood sugar levels (hyperglycemia), in some cases serious and associated with coma or death, have been reported in patients taking ABILIFY and medicines like it

If you have any questions about your health or medicines, talk to your healthcare professional.